Violations of Article 4, Paragraph 1 hereof by establishing any Biobank without an approval from the Competent Authority shall be subject to a fine of no less than two million New Taiwan Dollars (NT$ 2,000,000) and no more than ten million New Taiwan Dollars (NT$ 10,000,000). Any and all biological specimens and other data and information stored in such a Biobank shall be destroyed. However, in the event that the qualification and condition requirements for the establishment set for in Article 4, paragraph 2 hereof are met and that other relevant procedures may be supplemented or corrected, the violator may be first ordered to make such supplement or correction within a prescribed deadline.
Violations of Article 14, Paragraph 1 hereof or Article 14, Paragraph 3 by failing to submit a follow-up plan to the competent authority for a prior approval with regard to of any future cessation of Biobank operation within the time specified; or by failing to comply with the approved follow-up plan shall be subject to a fine of no less than two million New Taiwan Dollars (NT$ 2,000,000) and no more than ten million New Taiwan Dollars (NT$ 10,000,000).
Violations of Article 15, Paragraph 1 or Paragraph 2 by failing to apply to the Competent Authority for approval shall be subject a fine of no less than two million New Taiwan Dollars (NT$ 2,000,000) and no more than ten million New Taiwan Dollars (NT$ 10,000,000). Any exported biological specimens and related data and information shall be immediately destroyed.
Violations of Article 30 by failing to destroy any biological specimens and related data and information as required by law shall be subject to a fine of no less than two million New Taiwan Dollars (NT$ 2,000,000) and no more than ten million New Taiwan Dollars (NT$ 10,000,000).
Where the circumstances set forth in the preceding four paragraphs constitute a serious offense, the Competent Authority may also revoke the establishment permit of the violator.

When engaging in any of the following violations, an Operator shall be subject to a fine of no less than five hundred thousand New Taiwan Dollars (NT$ 500,000) and no more than two million and five hundred thousand New Taiwan Dollars (NT$ 2,500,000); and may be ordered to undertake timely corrective actions. An Operator who fails to timely undertake such corrective actions shall be subject to an additional fine imposed for each failure:
1.violating Article 5, Paragraph 1 or 3 by failing to establish an ethics committee, or failing to submit the management and application matters of the Biobank to the ethics committee for review and supervision, or failing to submit same to the Competent Authority for approval; violating Article 5, Paragraph 2 by allowing unlawful composition of the ethics committee; or violating Article 5, Paragraph 6 by failing to recuse from a conflict of interests.
2.violating Article 6, Paragraphs 1-3 or Article 7 by collecting biological specimens; or violating Article 6, Paragraph 4 by failing to submit the agreement of consent to the ethics committee for review and approval.
3.violating Article 12 by disclosing any confidences or other personal data or information of a participant that is known or obtained as a result of the work.
4.violating Article 13, Paragraph 1 by failing to stipulate or disclose rules regarding information security, or for the reason that the management of biological specimens and related data and information violates any information security regulations; or failing to comply with Article 13, Paragraph 2 requiring that the information security rules pass the review of the concerned ethics committee or submitted to the Competent Authority for records.
5.violating Article 18, Paragraph 1 by failing to process the biological specimens and related data and information so that the participant ’ s identity is unable to be determined; or violating Article 18, Paragraph 4 by failing to adopt necessary measures to maintain the confidentiality of information contained in the documents that are unable to be separated from the information which can determine the identity of a participant; or violating Article 18, Paragraph 5.
6.violating Article 18, Paragraph 2 by failing to encrypt and independently administer information that can determine the identity of an individual participant, failing to establish a review and control procedure for cross referencing the personal information with the biological specimens and relevant data and information, or failing to immediately restore such information after each necessary use; or violating Article 18, Paragraph 3 by failing to cross reference data with information by means that the participant ’ s identity is unable to be determined, or by failing to immediately restore such information after cross reference.
7.violating Article 20 by using biological specimens, derivatives, and related data and information for the purposes other than biomedical research.
In the event of any of the violations set forth in the preceding paragraphs, the Competent Authority may order a temporary cessation of the operation of the Biobank pending timely corrective actions; where the circumstances constitute a serious offense, the Competent Authority may also revoke the establishment licensure of the violator.

When engaging in any of the following violations, a Operator shall be subject to a fine of no less than two hundred thousand New Taiwan Dollars (NT$ 200,000) and no more than two million and one million New Taiwan Dollars (NT$ 1,000,000); and may be ordered to undertake timely corrective actions. An Operator who fails to timely undertake such corrective actions shall be subject to an additional fine imposed for each failure:
1.violating Article 8, Paragraph 1 for refusing a Participant ’ s requests; or violating Article 8, Paragraph 2 by failing to destroy or notify the concerned third party to destroy biological specimens and related data and information provided by a withdrawing Participant.
2.violating Article 16, Paragraph 2 by failing to use or provide to any third party the biological specimens and related data and information pursuant to the scope, duration, and method as agreed to by the Participant.
3.violating the regulations stipulated pursuant to Article 21, Paragraph 2.
4.violating Article 22 by failing to regularly publish biomedical studies and results.
Violations of Article 29 by collecting or using biological specimens in biomedical research being not based on the population groups or specific population groups shall be subject to fines a fine of no less than two hundred thousand New Taiwan Dollars (NT$ 200,000) and no more than two million and one million New Taiwan Dollars (NT$ 1,000,000). The violators may be ordered to undertake timely corrective actions. An Operator who fails to timely undertake such corrective actions shall be subject to an additional fine imposed for each failure.

When engaging in any of the following violations, a person shall be subject to a fine of no less than sixty thousand New Taiwan Dollars (NT$ 60,000) and no more than two million and three hundred thousand New Taiwan Dollars (NT$ 300,000); and may be ordered to undertake timely corrective actions. The person who fails to timely undertake such corrective actions shall be subject to an additional fine imposed for each failure:
1.where any person other than an Operator violates Article 5, Paragraph 3.
2.where an Operator violates Article 6, Paragraph 4 by failing to submit the agreement of consent to the Competent Authority for records.
3.violating Article 11, Paragraph 1 by failing to report to the Competent Authority the infringement on the biological specimens, or related data or information, or where an Operator fails to immediately investigate the situations and notify the relevant participants in an appropriate manner; or violating Paragraph 2 of the same Article.
4.where any person other than an Operator violates Article 12 by divulging any confidence or other personal data or information of a Participant that is known or held by him/her as a result of his/her work.
5.violating Article 16, Paragraph 1 by obtaining materials that are used for biomedical research being based on population groups or specific population groups from a Biobank whose establishment has not been approved.

With regard to the sanctions set forth in the preceding four articles, the Operation who actually committed the act of violation shall be subject to a fine of no less than thirty thousand New Taiwan Dollars (NT$ 30,000) and no more than three hundred thousand New Taiwan Dollars (NT$ 300,000).
In the event that an individual violator referred to in the preceding Paragraph is a licensed healthcare worker, he/she shall also be punished in accordance with laws and regulations governing healthcare professionals.

In the event that the establishment of a Biobank is in violation of the regulations stipulated by the Competent Authority pursuant to Article 4, Paragraph 2, in additional to the penalties set forth herein, the Competent Authority may order a timely corrective action. If necessary, the Operator may be ordered to cease operations pending the correction actions. Where the nature of the offense is serious, the establishment permit of the violator may be revoked.